BEUDAMED
    FDA Adverse Event Death Summary report: N

    OEC ELITE CFD

    MDR report key: 24687627 · Received March 25, 2026

    Report

    Report Number
    1720753-2026-00001
    Event Type
    Death
    Date Received
    March 25, 2026
    Report Date
    March 25, 2026
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    OBW
    UDI-DI
    00840682121729
    PMA / PMN Number
    K192819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE, AND ANY POTENTIAL CONTRIBUTION OF THE DEVICE TO THE PATIENT OUTCOME, IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. LEGAL MANUFACTURER: SURGERY SLC: 384 N WRIGHT BROTHERS DR USA SALT LAKE CITY, UT 84116.

    Description of Event or Problem · 0

    ON (B)(6) 2026, AN INTERNAL EMAIL ORIGINATING FROM A CUSTOMER SITE WAS SENT TO A GE HEALTHCARE (GEHC) SALES REPRESENTATIVE INDICATING THAT A PATIENT EXPIRATION HAD OCCURRED AND THAT THE EVENT WAS POTENTIALLY ASSOCIATED WITH A GE HEALTHCARE C ARM. THE CONTENT OF THE CUSTOMER¿S EMAIL DESCRIBED THE FOLLOWING SEQUENCE OF EVENTS: 1. THE PATIENT PRESENTED FOR A ROUTINE UROLOGIC PROCEDURE REQUIRING INTRAOPERATIVE FLUOROSCOPY. 2. THE GEHC C ARM EQUIPMENT WAS MANEUVERED TO OBTAIN THE DESIRED VIEW. 3. THE CLINICAL TEAM DID NOT RECOGNIZE AN IMAGE INVERSION AND SUBSEQUENTLY REQUESTED ADMINISTRATION OF CONTRAST DYE. 4. AN INCORRECT DOSE OF CONTRAST DYE WAS ADMINISTERED, WHICH THE CUSTOMER REPORTED AS LEADING TO ¿CATASTROPHIC OUTCOMES,¿ INCLUDING A REPORTED PATIENT EXPIRATION. NO ADDITIONAL INFORMATION REGARDING THE DATE OF THE PROCEDURE, SPECIFIC DEVICE SETTINGS, IMAGES, WORKFLOW STEPS, OR ANY DIRECT OBSERVATIONS FROM GEHC PERSONNEL HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753883 OEC ELITE CFD FLUOROSCOPIC X-RAY OBW GE OEC MEDICAL SYSTEMS, INC ELITE 31 ECO TOUCH FBXXTP00126 00840682121729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death